Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 1:40 AM
NCT ID:
NCT07153094
Brief Summary:
This trial will enroll 47 subjects who will be be treated with the IBA PROTEUS® PLUS Proton Beam radiation Therapy (PBT) medical device.
The trial aims to assess the safety and efficacy of PROTEUS® PLUS for radiation therapy to oncology patients, and to provide a clinical basis for product registration application.
Detailed Description:
The trial is structured in two distinct phases. Phase 1 - Clinical Trial: This phase spans from the initial screening through to 90 days post-treatment. Its primary objective is to assess the efficacy and safety of PROTEUS® PLUS in accordance with the regulatory requirements set by the National Medical Products Administration (NMPA) for product registration. Phase 2 - Long-Term Follow-Up: Extending up to five years after treatment, this phase aims to monitor the long-term efficacy and safety of PROTEUS® PLUS. Periodic reports will be submitted in compliance with NMPA guidelines.
Study:
NCT07153094
Study Brief:
Protocol Section:
NCT07153094